Supervised Walking Groups as a Model to Increase Physical Activity in Type 2 Diabetes

NCT01115205 | Completed

• 1 other identifier: CE 1264
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to evaluate the impact of an exercise programme organized into supervised walking groups on metabolic control, functional capacity and overall quantity of physical activity in subjects with type 2 diabetes.

Conditions

Type 2 Diabetes

Keywords

Exercise, Walking, Type 2 diabetes, Therapy

Outcome Measures

Primary Outcomes (1)

• Change in haemoglobin A1c (HbA1c) levels

  The measurement of HbA1c is carried out with a DCCT-aligned method.

  4 months

Secondary Outcomes (12)

• Change in Body weight

  4 months

• Change in Fasting plasma glucose levels

  4 months

• Change in Total Cholesterol levels

  4 months

• Change in HDL Cholesterol levels

  4 months

• Change in LDL Cholesterol levels

  4 months

Study Arms (2)

Supervised walking groups

EXPERIMENTAL

Patients included in walking groups, under the supervision of a qualified personal trainer.

Behavioral: Supervised walking

Controls

ACTIVE COMPARATOR

Patients receiving the standard counselling procedures of the Verona Diabetic Clinic.

Behavioral: Standard counselling procedure

Interventions

Supervised walking BEHAVIORAL

Walk training, 3 sessions per week for 4 months, under the supervision of a qualified personal trainer.

Supervised walking groups

Standard counselling procedure BEHAVIORAL

Verbal and written information about the benefits of exercise and instructions aimed to encourage physical activity. In addition, one group session of counselling on these issues.

Controls

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diabetes known for at least 2 yr
• physical inactivity
• haemoglobin (Hb)A1c between 6.5-9.9%
• treatment with oral hypoglycaemic agents alone or associated with a bed-time insulin injection
• willingness to participate in a programme of regular physical activity

You may not qualify if:

• moderate-severe autonomic or somatic neuropathy
• severe lower limb vasculopathy
• pre-proliferative or proliferative active retinopathy
• moderate to severe chronic renal failure
• unstable angina or recent (in the previous 3 months) myocardial infarction
• acute intercurrent diseases
• acute metabolic decompensation (blood glucose \>300 mg/dl or ketonuria in two consecutive checks)
• use of beta-blocker drugs
• subjects unable to complete a 6-min walk test

Sponsors & Collaborators

• Universita di Verona: lead

Related Publications (1)

• Negri C, Bacchi E, Morgante S, Soave D, Marques A, Menghini E, Muggeo M, Bonora E, Moghetti P. Supervised walking groups to increase physical activity in type 2 diabetic patients. Diabetes Care. 2010 Nov;33(11):2333-5. doi: 10.2337/dc10-0877.

  PMID: 20980426 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Paolo Moghetti, M.D., Ph.D.

  Universita di Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: May 4, 2010
• Study Start: March 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2009
• Last Updated: May 5, 2010

Record last verified: 2010-05